Induction of LaborNCT03033264
Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.
A study testing Dinoprostone and Double lumen cervical ripening balloon. in people with Induction of Labor, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value: 1. Dinoprostone in women with a BMI>30. 2. Dinoprostone in women with a BMI<30. 3. Cervical ripening balloon in women with a BMI>30. 4. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Dinoprostone and Double lumen cervical ripening balloon.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2017to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any pregnant woman at term with an obstetric indication for labor induction.
Who cannot join
- Previous cesarean section.
- Positive Oxytocin challenge test.
- Positive contraction stress test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Labor Induction With Dinoprostone and a Cervical Ripening Balloon in Women With a BMI>30 as Oppose With a BMI<30.
Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value:
- Dinoprostone in women with a BMI>30.
- Dinoprostone in women with a BMI<30.
- Cervical ripening balloon in women with a BMI>30.
- Cervical ripening balloon in women with a BMI<30. The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.
Read the detailed description
The study is a randomized controlled test in which women with a BMI>30 and women with a BMI<30 will sign an informed consent and then divided to 4 groups depending on the mode of labor induction and BMI value:
- Dinoprostone in women with a BMI>30.
- Dinoprostone in women with a BMI<30.
- Cervical ripening balloon in women with a BMI>30.
- Cervical ripening balloon in women with a BMI<30. All subjects participating in the study will be induced for obstetrical indications alone.
The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.
The participants will finish participation in the study after delivery.
- Conditions
- Induction of Labor
- Being tested
- Dinoprostone, Double lumen cervical ripening balloon.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinoprostoneDrug
Also called Prostaglandin E2
10 mg of a Dinoprostone vaginal insert.
Double lumen cervical ripening balloon.Device
Double lumen cervical ripening balloon.
| Study group | Role | What they receive |
|---|---|---|
| BMI>30+Dinoprostone | Experimental | Women with a BMI>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert. Receives: Drug: Dinoprostone |
| BMI<30+Dinoprostone | Experimental | Women with a BMI<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert. Receives: Drug: Dinoprostone |
| BMI>30+Cervical ripening balloon | Experimental | Women with a BMI>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon. Receives: Device: Double lumen cervical ripening balloon. |
| BMI<30+Cervical ripening balloon | Experimental | Women with a BMI<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon. Receives: Device: Double lumen cervical ripening balloon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery
Vaginal delivery in oppose to cesarean section.
Measured: Up to 5 days.
Secondary outcomes (3)
Time to delivery
Time from insertion of induction device\drug until delivery.
Measured: Up to 5 days.
Induction success.
Cervical dilatation and effacement after cessation of induction.
Measured: Up to 5 days.
Neonatal complications and outcome.
Any neonatal complications as mentioned In the neonate's electronic file.
Measured: Up to 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion31 Jul 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- ROY LAUTERBACH, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033264
- Sponsor's protocol ID
- 0192-19-RMB
- Status last verified
- Oct 2020
- First submitted
- 24 Dec 2016
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Labor Induction With Dinoprostone and a Cervical Ripening Balloon in Women With a BMI>30 as Oppose With a BMI<30.
- ClinicalTrials.gov ID
- NCT03033264
- Acronym / sponsor ID
- 0192-19-RMB
- Conditions
- Induction of Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value:
- Dinoprostone in women with a BMI>30.
- Dinoprostone in women with a BMI<30.
- Cervical ripening balloon in women with a BMI>30.
- Cervical ripening balloon in women with a BMI<30. The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.
Detailed description
The study is a randomized controlled test in which women with a BMI>30 and women with a BMI<30 will sign an informed consent and then divided to 4 groups depending on the mode of labor induction and BMI value:
- Dinoprostone in women with a BMI>30.
- Dinoprostone in women with a BMI<30.
- Cervical ripening balloon in women with a BMI>30.
- Cervical ripening balloon in women with a BMI<30. All subjects participating in the study will be induced for obstetrical indications alone.
The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.
The participants will finish participation in the study after delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMI>30+Dinoprostone | Experimental | Drug: DinoprostoneWomen with a BMI>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert. |
| BMI<30+Dinoprostone | Experimental | Drug: DinoprostoneWomen with a BMI<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert. |
| BMI>30+Cervical ripening balloon | Experimental | Device: Double lumen cervical ripening balloon.Women with a BMI>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon. |
| BMI<30+Cervical ripening balloon | Experimental | Device: Double lumen cervical ripening balloon.Women with a BMI<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any pregnant woman at term with an obstetric indication for labor induction.
Key exclusion criteria (3 listed)
- Previous cesarean section.
- Positive Oxytocin challenge test.
- Positive contraction stress test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DinoprostoneAlso: Prostaglandin E210 mg of a Dinoprostone vaginal insert. | Drug | BMI<30+Dinoprostone, BMI>30+Dinoprostone |
| Double lumen cervical ripening balloon.Double lumen cervical ripening balloon. | Device | BMI<30+Cervical ripening balloon, BMI>30+Cervical ripening balloon |
Primary outcome
Mode of delivery
Time frame: Up to 5 days.
Vaginal delivery in oppose to cesarean section.
3 secondary outcomes
Time to delivery
Time frame: Up to 5 days.
Induction success.
Time frame: Up to 5 days.
Neonatal complications and outcome.
Time frame: Up to 5 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROY LAUTERBACH, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dinoprostone and Double lumen cervical ripening balloon. in people with Induction of Labor, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of delivery (time frame: Up to 5 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03033264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.